Libby Laboratories, Inc.
FDA inspection history in Berkeley, California, 2025
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2025: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2025One warning letter and one Form 483, at Berkeley, California.
Cited most
Across all Libby Laboratories observations on file
- 21 CFR 211.165(b)Testing and release for distribution1
- 21 CFR 211.84(a)Testing and approval or rejection of components, drug product containers, and closures1
The complete Libby Laboratories file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Berkeley, California
One warning letter and one Form 483 · 2025 · 2 observations
Latest: Warning letter, Jun 27, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-06-27 | Warning letter Warning letter | Berkeley, California | — | $99 |
| 2025-03-14 | 483 Form 483 | Berkeley, California | 2 | $99 |
Investigators on these documents
FEI number 2912388 · most recent document Jun 27, 2025
About Libby Laboratories, Inc.
How many FDA Form 483s has Libby Laboratories, Inc. received?
FDA Intel has 1 Form 483 on file for Libby Laboratories, Inc.; the most recent is dated Mar 14, 2025.
When was Libby Laboratories, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Libby Laboratories, Inc. is a Form 483 dated Mar 14, 2025, for the site in Berkeley, California.
What did FDA cite at Libby Laboratories, Inc.?
The regulations cited most in the observations on file for Libby Laboratories, Inc. are 21 CFR 211.165(b) (Testing and release for distribution), 1 time; 21 CFR 211.84(a) (Testing and approval or rejection of components, drug product containers, and closures), 1 time.
Has Libby Laboratories, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Libby Laboratories, Inc.; the most recent is dated Jun 27, 2025.